Treatment of Periodontal Intra-bony DefectsEarly Phase 1NCT06625528
The Present Study Was Performed to Evaluate the Efficacy of Lyophilized-PRF in Treatment of Periodontal Intra-bony Defects
A Early Phase 1 study testing open flap debridement in people with Treatment of Periodontal Intra-bony Defects, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The present study will be performed to evaluate the efficacy of lyophilized platelet-rich fibrin alone and combined with nanocrystalline hydroxyapatite in treatment of periodontal intra-bony defects through: 1. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Treatment of Periodontal Intra-bony Defects
- What is being tested?
- open flap debridement
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 19 Nov 2023to May 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All periodontitis patients to be included in this study should be diagnosed as having stage III periodontitis with probing pocket depth (PPD) ≥ 6 mm, and clinical attachment loss (CAL) ≥ 5mm.
- 2- or 3-wall intra-bony interproximal defect with depth ≥3 mm, a width of ≥3 mm at its most coronal part and 45-55-degree angulation will be selected in order to reduce defect variability.
- All patients will be free from any systemic diseases according to the American Dental Academy general guidelines for referring dental patients to specialists and other care settings
Who cannot join
- Any patients with any systemic condition that contraindicate any surgical intervention.
- Pregnant or lactating females, smokers, or alcoholic patients.
- Patients with intra-bony defects received drugs that affect bone turnover such as (chemotherapy and radiotherapy).
- History of periodontal therapy and antibiotic administration in the last 6 months.
- Patients taking any medicine which may affect the function of platelet (i.e., aspirin) in the previous 3 months.
- Miller grade II or greater mobility, furcation involvement as well as one-wall defects and interdental craters.
- Patients with unacceptable oral hygiene after the re-evaluation of phase I therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Lyophilized Platelet-Rich Fibrin in Treatment of Periodontal Intra-Bony Defects (A Comparative Clinical, Radiographic and Biochemical Study)
The present study will be performed to evaluate the efficacy of lyophilized platelet-rich fibrin alone and combined with nanocrystalline hydroxyapatite in treatment of periodontal intra-bony defects through:
- Primary outcomes:
- The clinical parameters including: Probing pocket depth (PPD) reduction and clinical attachment level (CAL) gain.
- The radiographic parameters including: Marginal bone level (MBL), bone-defect fill.
- Secondary outcome: The level of BMP-2 in Gingival crevicular fluid (GCF).
Read the detailed description
Periodontitis is a multi-factorial inflammatory process affecting the periodontal tissues. Among the characteristic signs of periodontal disease is loss of alveolar bone support. The risk of further alveolar bone loss and the probability of tooth loss increases with the presence of intra-bony defects.
Periodontal intra-bony defects (IBDs) are osseous defects with specific morphology, the bottom of these defects is located more apically than the alveolar crest and they are surrounded by bony walls on 1-, 2-, or 3- sides, with the tooth root forming the additional wall. The prevalence of these defects is significantly lower than supra-crestal periodontal defects.
Among the main goals of periodontal therapy is to regenerate the lost periodontal tissues after arresting the progress of the disease. Surgical management of periodontally affected sites includes conventional and regenerative procedures. The conventional modality of surgical debridement allows for reliable access to root surfaces leading only to healing by repair. While the regenerative treatment options allow for the regeneration of destroyed periodontal ligament and bone. Guided tissue regeneration (GTR), placement of bone grafting materials, the addition of biologic mediators and a combination of such techniques are the different forms of periodontal regenerative techniques.
Bone grafts (BGs) and substitutes are classified into autogenic, allogenic, xenogenic and synthetic bone grafts. Synthetic nanocrystalline hydroxyapatite (NCHA) has been extensively applied as bone graft replacement material and characterized by its osteoconductive properties and improved osseointegrative features. The size of the particle was found to be around 18 nm, allowing for quicker vital bone substitution. It has been proved that NCHA can enhance the adhesion of the bone formative cells (osteoblasts) more than micromaterials. Furthermore, the nano-sized particles provide special properties to NCHA such as ahydrated surface layer, a large surface/volume ratio, this layer is actively involved in the homeostasis process, ionic exchange and other techniques involved in the osteogenesis regulation. NCHA is osteoconductive but has inferior osteoinductive properties; therefore, one of the efforts to increase the ability of this material is to combine it with other bioactive materials such as platelet-rich fibrin (PRF).
Platelet-rich fibrin is a second-generation platelet concentrate that has been widely used in the treatment of bone deficiency and its main action is derived from its high content of platelets that release many growth factors (GFs) and cytokines. However, freshly prepared PRF must be used immediately in order to retain the bioactivity of growth factors. In addition, the bio-degradation rate of PRF is fast and irregular, along with the rapid release of growth factors, and then enzymatically hydrolyzed.
The lyophilization of PRF by vacuum freeze dryer was found to provide a dense three-dimensional fibrin network, better storage stability with a longer half-life and preservation of GFs. Lyophilized platelet-rich fibrin (Ly-PRF) showed adaptability as a viable biomaterial for application as a craniofacial bio-scaffold due to, the advantage of lowering the difficulty in application, providing a newly grown tissue with straightforward access to multiple GFs as well as, sustained release GFs presenting a better tissue regeneration process and bone tissue reconstruction.
It was proven that, Ly-PRF significantly improve the osteogenic differentiation of bone marrow mesenchymal stem cell (BMSC) in vitro through the upregulation of osteogenic markers: collagen type I, osteopontin (OPN), osteocalcin (OCN), and bone morphogenetic protein 2 (BMP-2). BMP-2 is described as being osteoinductive, which is capable of inducing and enhancing bone growth and formation, and it also promotes cell chemotaxis, proliferation and differentiation towards the osteogenic pathway.
The present clinical trial will be performed to clarify and shed some light on Ly-PRF in periodontal regeneration
- Being tested
- open flap debridement
- Keywords
- periodontitis, lyophilized-PRF, Periodontal intra-Bony Defects, Periodontal angular bone defect
- Medical subject headings
- Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
open flap debridementBiological
Also called lyophilized platelet rich fibrin combined with open flap debridement, combination of lyophilized platelet rich fibrin and nano-crystalline hydroxyapatite bone substitute
does lyophilized platelet rich fibrin combined with open flap debridement or combination of open flap debridement, lyophilized platelet rich fibrin and nano-crystalline hydroxyapatite bone substitute can add benefits to open flap debridement alone or not
| Study group | Role | What they receive |
|---|---|---|
| open flap debridement | Placebo comparator | Immediately before surgery, patients rinsed with 0.12% chlorhexidine digluconate and povidone iodine solution was used to perform extra-oral antisepsis. The surgical site was anaesthetized. A mucoperiosteal flap was elevated and reflected followed by thorough debridement of all inflammatory granulation tissue from IBD until a sound, healthy bone surface was obtained. Root surface debridement was also performed. Copious irrigation with normal saline solution. The flap was repositioned and sutured. Receives: Biological: open flap debridement |
| lyophilized platelet rich fibrin | Active comparator | Immediately before surgery, patients rinsed with 0.12% chlorhexidine digluconate and povidone iodine solution was used to perform extra-oral antisepsis. The surgical site was anaesthetized. A mucoperiosteal flap was elevated and reflected followed by thorough debridement of all inflammatory granulation tissue from IBD until a sound, healthy bone surface was obtained. Root surface debridement was also performed. Copious irrigation with normal saline solution. The lyophilized-PRF granules was hydrated with a few drops of normal saline then, it was applied and packed to fill defect. The flap was repositioned and sutured. Receives: Biological: open flap debridement |
| lyo-PRF and nanocrystalline hydroxyapatite bone graft | Active comparator | Immediately before surgery, patients rinsed with 0.12% chlorhexidine digluconate and povidone iodine solution was used to perform extra-oral antisepsis. The surgical site was anaesthetized. A mucoperiosteal flap was elevated and reflected followed by thorough debridement of all inflammatory granulation tissue from IBD until a sound, healthy bone surface was obtained. Root surface debridement was also performed. Copious irrigation with normal saline solution. A mixture of Ly-PRF and n-HA (1:1by weight) was hydrated with a few drops of normal saline then, it was applied and packed to fill the defect. The flap was repositioned and sutured. Receives: Biological: open flap debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
radiographic parameters
The radiographic parameters including: Bone-defect fill in mm.
Measured: baseline, 3, 6, and 9 months after treatment
clinical parameters
The clinical parameters including: Clinical attachment level (CAL) gain in mm.
Measured: baseline, 3, 6, and 9 months after treatment.
Secondary outcomes (1)
biochemical evaluation
The level of BMP-2 (Pg/ml) in Gingival crevicular fluid (GCF).
Measured: baseline, 1, 4 and 12 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2024
- Study start19 Nov 2023
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Treatment of Periodontal Intra-bony DefectsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The patients selected in this study will be randomly divided into 3 groups: Group I: Periodontitis patients with an intra-bony defect will be treated by open flap debridement. Group II: Periodontitis patients with an intra-bony defect will be treated by open flap debridement combined with the application of lyophilized platelet-rich fibrin. Group III: Periodontitis patients with an intra-bony defect will be treated by open flap debridement and lyophilized platelet-rich fibrin combined with nanocrystalline hydroxyapatite bone substitute. All patients will be evaluated clinically, radiographically and biochemically
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alaa El-Dein Mohamed Maamoun Salatein, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06625528
- Sponsor's protocol ID
- periodontal treatments
- Status last verified
- Oct 2024
- First submitted
- 26 Sep 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Anoixiadou S, Parashis A, Vouros I. Minimally Invasive Non-Surgical Technique in the Treatment of Intrabony Defects-A Narrative Review. Dent J (Basel). 2023 Jan 11;11(1):25. doi: 10.3390/dj11010025.
PubMed 36661562Tavelli L, Chen CJ, Barootchi S, Kim DM. Efficacy of biologics for the treatment of periodontal infrabony defects: An American Academy of Periodontology best evidence systematic review and network meta-analysis. J Periodontol. 2022 Dec;93(12):1803-1826. doi: 10.1002/JPER.22-0120. Epub 2022 Oct 24.
PubMed 36279121Zhao R, Yang R, Cooper PR, Khurshid Z, Shavandi A, Ratnayake J. Bone Grafts and Substitutes in Dentistry: A Review of Current Trends and Developments. Molecules. 2021 May 18;26(10):3007. doi: 10.3390/molecules26103007.
PubMed 34070157Shaikh MS, Zafar MS, Alnazzawi A, Javed F. Nanocrystalline hydroxyapatite in regeneration of periodontal intrabony defects: A systematic review and meta-analysis. Ann Anat. 2022 Feb;240:151877. doi: 10.1016/j.aanat.2021.151877. Epub 2021 Dec 2.
PubMed 34864225Liu X, Yin M, Li Y, Wang J, Da J, Liu Z, Zhang K, Liu L, Zhang W, Wang P, Jin H, Zhang B. Genipin modified lyophilized platelet-rich fibrin scaffold for sustained release of growth factors to promote bone regeneration. Front Physiol. 2022 Sep 30;13:1007692. doi: 10.3389/fphys.2022.1007692. eCollection 2022.
PubMed 36246111Wang Z, Han L, Sun T, Wang W, Li X, Wu B. Preparation and effect of lyophilized platelet-rich fibrin on the osteogenic potential of bone marrow mesenchymal stem cells in vitro and in vivo. Heliyon. 2019 Nov 1;5(10):e02739. doi: 10.1016/j.heliyon.2019.e02739. eCollection 2019 Oct.
PubMed 31720476Ngah NA, Dias GJ, Tong DC, Mohd Noor SNF, Ratnayake J, Cooper PR, Hussaini HM. Lyophilised Platelet-Rich Fibrin: Physical and Biological Characterisation. Molecules. 2021 Nov 25;26(23):7131. doi: 10.3390/molecules26237131.
PubMed 34885714Zhu L, Liu Y, Wang A, Zhu Z, Li Y, Zhu C, Che Z, Liu T, Liu H, Huang L. Application of BMP in Bone Tissue Engineering. Front Bioeng Biotechnol. 2022 Mar 31;10:810880. doi: 10.3389/fbioe.2022.810880. eCollection 2022.
PubMed 35433652Tsoromokos N, Parinussa S, Claessen F, Moin DA, Loos BG. Estimation of Alveolar Bone Loss in Periodontitis Using Machine Learning. Int Dent J. 2022 Oct;72(5):621-627. doi: 10.1016/j.identj.2022.02.009. Epub 2022 May 13.
PubMed 35570013
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Lyophilized Platelet-Rich Fibrin in Treatment of Periodontal Intra-Bony Defects (A Comparative Clinical, Radiographic and Biochemical Study)
- ClinicalTrials.gov ID
- NCT06625528
- Acronym / sponsor ID
- periodontal treatments
- Keywords
- periodontitis, lyophilized-PRF, Periodontal intra-Bony Defects, Periodontal angular bone defect
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 19 Nov 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 3 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The present study will be performed to evaluate the efficacy of lyophilized platelet-rich fibrin alone and combined with nanocrystalline hydroxyapatite in treatment of periodontal intra-bony defects through:
- Primary outcomes:
- The clinical parameters including: Probing pocket depth (PPD) reduction and clinical attachment level (CAL) gain.
- The radiographic parameters including: Marginal bone level (MBL), bone-defect fill.
- Secondary outcome: The level of BMP-2 in Gingival crevicular fluid (GCF).
Detailed description
Periodontitis is a multi-factorial inflammatory process affecting the periodontal tissues. Among the characteristic signs of periodontal disease is loss of alveolar bone support. The risk of further alveolar bone loss and the probability of tooth loss increases with the presence of intra-bony defects.
Periodontal intra-bony defects (IBDs) are osseous defects with specific morphology, the bottom of these defects is located more apically than the alveolar crest and they are surrounded by bony walls on 1-, 2-, or 3- sides, with the tooth root forming the additional wall. The prevalence of these defects is significantly lower than supra-crestal periodontal defects.
Among the main goals of periodontal therapy is to regenerate the lost periodontal tissues after arresting the progress of the disease. Surgical management of periodontally affected sites includes conventional and regenerative procedures. The conventional modality of surgical debridement allows for reliable access to root surfaces leading only to healing by repair. While the regenerative treatment options allow for the regeneration of destroyed periodontal ligament and bone. Guided tissue regeneration (GTR), placement of bone grafting materials, the addition of biologic mediators and a combination of such techniques are the different forms of periodontal regenerative techniques.
Bone grafts (BGs) and substitutes are classified into autogenic, allogenic, xenogenic and synthetic bone grafts. Synthetic nanocrystalline hydroxyapatite (NCHA) has been extensively applied as bone graft replacement material and characterized by its osteoconductive properties and improved osseointegrative features. The size of the particle was found to be around 18 nm, allowing for quicker vital bone substitution. It has been proved that NCHA can enhance the adhesion of the bone formative cells (osteoblasts) more than micromaterials. Furthermore, the nano-sized particles provide special properties to NCHA such as ahydrated surface layer, a large surface/volume ratio, this layer is actively involved in the homeostasis process, ionic exchange and other techniques involved in the osteogenesis regulation. NCHA is osteoconductive but has inferior osteoinductive properties; therefore, one of the efforts to increase the ability of this material is to combine it with other bioactive materials such as platelet-rich fibrin (PRF).
Platelet-rich fibrin is a second-generation platelet concentrate that has been widely used in the treatment of bone deficiency and its main action is derived from its high content of platelets that release many growth factors (GFs) and cytokines. However, freshly prepared PRF must be used immediately in order to retain the bioactivity of growth factors. In addition, the bio-degradation rate of PRF is fast and irregular, along with the rapid release of growth factors, and then enzymatically hydrolyzed.
The lyophilization of PRF by vacuum freeze dryer was found to provide a dense three-dimensional fibrin network, better storage stability with a longer half-life and preservation of GFs. Lyophilized platelet-rich fibrin (Ly-PRF) showed adaptability as a viable biomaterial for application as a craniofacial bio-scaffold due to, the advantage of lowering the difficulty in application, providing a newly grown tissue with straightforward access to multiple GFs as well as, sustained release GFs presenting a better tissue regeneration process and bone tissue reconstruction.
It was proven that, Ly-PRF significantly improve the osteogenic differentiation of bone marrow mesenchymal stem cell (BMSC) in vitro through the upregulation of osteogenic markers: collagen type I, osteopontin (OPN), osteocalcin (OCN), and bone morphogenetic protein 2 (BMP-2). BMP-2 is described as being osteoinductive, which is capable of inducing and enhancing bone growth and formation, and it also promotes cell chemotaxis, proliferation and differentiation towards the osteogenic pathway.
The present clinical trial will be performed to clarify and shed some light on Ly-PRF in periodontal regeneration
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- The patients selected in this study will be randomly divided into 3 groups: Group I: Periodontitis patients with an intra-bony defect will be treated by open flap debridement. Group II: Periodontitis patients with an intra-bony defect will be treated by open flap debridement combined with the application of lyophilized platelet-rich fibrin. Group III: Periodontitis patients with an intra-bony defect will be treated by open flap debridement and lyophilized platelet-rich fibrin combined with nanocrystalline hydroxyapatite bone substitute. All patients will be evaluated clinically, radiographically and biochemically
| Arm | Type | Receives |
|---|---|---|
| open flap debridement | Placebo comparator | Biological: open flap debridementImmediately before surgery, patients rinsed with 0.12% chlorhexidine digluconate and povidone iodine solution was used to perform extra-oral antisepsis. The surgical site was anaesthetized. A mucoperiosteal flap was elevated and reflected followed by thorough debridement of all inflammatory granulation tissue from IBD until a sound, healthy bone surface was obtained. Root surface debridement was also performed. Copious irrigation with normal saline solution. The flap was repositioned and sutured. |
| lyophilized platelet rich fibrin | Active comparator | Biological: open flap debridementImmediately before surgery, patients rinsed with 0.12% chlorhexidine digluconate and povidone iodine solution was used to perform extra-oral antisepsis. The surgical site was anaesthetized. A mucoperiosteal flap was elevated and reflected followed by thorough debridement of all inflammatory granulation tissue from IBD until a sound, healthy bone surface was obtained. Root surface debridement was also performed. Copious irrigation with normal saline solution. The lyophilized-PRF granules was hydrated with a few drops of normal saline then, it was applied and packed to fill defect. The flap was repositioned and sutured. |
| lyo-PRF and nanocrystalline hydroxyapatite bone graft | Active comparator | Biological: open flap debridementImmediately before surgery, patients rinsed with 0.12% chlorhexidine digluconate and povidone iodine solution was used to perform extra-oral antisepsis. The surgical site was anaesthetized. A mucoperiosteal flap was elevated and reflected followed by thorough debridement of all inflammatory granulation tissue from IBD until a sound, healthy bone surface was obtained. Root surface debridement was also performed. Copious irrigation with normal saline solution. A mixture of Ly-PRF and n-HA (1:1by weight) was hydrated with a few drops of normal saline then, it was applied and packed to fill the defect. The flap was repositioned and sutured. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All periodontitis patients to be included in this study should be diagnosed as having stage III periodontitis with probing pocket depth (PPD) ≥ 6 mm, and clinical attachment loss (CAL) ≥ 5mm.
- 2- or 3-wall intra-bony interproximal defect with depth ≥3 mm, a width of ≥3 mm at its most coronal part and 45-55-degree angulation will be selected in order to reduce defect variability.
- All patients will be free from any systemic diseases according to the American Dental Academy general guidelines for referring dental patients to specialists and other care settings
Key exclusion criteria (7 listed)
- Any patients with any systemic condition that contraindicate any surgical intervention.
- Pregnant or lactating females, smokers, or alcoholic patients.
- Patients with intra-bony defects received drugs that affect bone turnover such as (chemotherapy and radiotherapy).
- History of periodontal therapy and antibiotic administration in the last 6 months.
- Patients taking any medicine which may affect the function of platelet (i.e., aspirin) in the previous 3 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| open flap debridementAlso: lyophilized platelet rich fibrin combined with open flap debridement, combination of lyophilized platelet rich fibrin and nano-crystalline hydroxyapatite bone substitutedoes lyophilized platelet rich fibrin combined with open flap debridement or combination of open flap debridement, lyophilized platelet rich fibrin and nano-crystalline hydroxyapatite bone substitute can add benefits to open flap debridement alone or not | Biological | lyo-PRF and nanocrystalline hydroxyapatite bone graft, lyophilized platelet rich fibrin, open flap debridement |
Primary outcome
radiographic parameters
Time frame: baseline, 3, 6, and 9 months after treatment
The radiographic parameters including: Bone-defect fill in mm.
clinical parameters
Time frame: baseline, 3, 6, and 9 months after treatment.
The clinical parameters including: Clinical attachment level (CAL) gain in mm.
1 secondary outcome
biochemical evaluation
Time frame: baseline, 1, 4 and 12 weeks after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Background: PubMed 36661562Anoixiadou S, Parashis A, Vouros I. Minimally Invasive Non-Surgical Technique in the Treatment of Intrabony Defects-A Narrative Review. Dent J (Basel). 2023 Jan 11;11(1):25. doi: 10.3390/dj11010025.
- Background: PubMed 36279121Tavelli L, Chen CJ, Barootchi S, Kim DM. Efficacy of biologics for the treatment of periodontal infrabony defects: An American Academy of Periodontology best evidence systematic review and network meta-analysis. J Periodontol. 2022 Dec;93(12):1803-1826. doi: 10.1002/JPER.22-0120. Epub 2022 Oct 24.
- Background: PubMed 34070157Zhao R, Yang R, Cooper PR, Khurshid Z, Shavandi A, Ratnayake J. Bone Grafts and Substitutes in Dentistry: A Review of Current Trends and Developments. Molecules. 2021 May 18;26(10):3007. doi: 10.3390/molecules26103007.
- Background: PubMed 34864225Shaikh MS, Zafar MS, Alnazzawi A, Javed F. Nanocrystalline hydroxyapatite in regeneration of periodontal intrabony defects: A systematic review and meta-analysis. Ann Anat. 2022 Feb;240:151877. doi: 10.1016/j.aanat.2021.151877. Epub 2021 Dec 2.
- Background: PubMed 36246111Liu X, Yin M, Li Y, Wang J, Da J, Liu Z, Zhang K, Liu L, Zhang W, Wang P, Jin H, Zhang B. Genipin modified lyophilized platelet-rich fibrin scaffold for sustained release of growth factors to promote bone regeneration. Front Physiol. 2022 Sep 30;13:1007692. doi: 10.3389/fphys.2022.1007692. eCollection 2022.
- Background: PubMed 31720476Wang Z, Han L, Sun T, Wang W, Li X, Wu B. Preparation and effect of lyophilized platelet-rich fibrin on the osteogenic potential of bone marrow mesenchymal stem cells in vitro and in vivo. Heliyon. 2019 Nov 1;5(10):e02739. doi: 10.1016/j.heliyon.2019.e02739. eCollection 2019 Oct.
- Background: PubMed 34885714Ngah NA, Dias GJ, Tong DC, Mohd Noor SNF, Ratnayake J, Cooper PR, Hussaini HM. Lyophilised Platelet-Rich Fibrin: Physical and Biological Characterisation. Molecules. 2021 Nov 25;26(23):7131. doi: 10.3390/molecules26237131.
- Background: PubMed 35433652Zhu L, Liu Y, Wang A, Zhu Z, Li Y, Zhu C, Che Z, Liu T, Liu H, Huang L. Application of BMP in Bone Tissue Engineering. Front Bioeng Biotechnol. 2022 Mar 31;10:810880. doi: 10.3389/fbioe.2022.810880. eCollection 2022.
- Results publication: PubMed 35570013Tsoromokos N, Parinussa S, Claessen F, Moin DA, Loos BG. Estimation of Alveolar Bone Loss in Periodontitis Using Machine Learning. Int Dent J. 2022 Oct;72(5):621-627. doi: 10.1016/j.identj.2022.02.009. Epub 2022 May 13.
- Combination of Nanocrystalline Hydroxyapatite and Injectable Platelet-Rich Fibrin on Bone Graft Materials for Alveolar Bone PreservationLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing open flap debridement in people with Treatment of Periodontal Intra-bony Defects, run by Al-Azhar University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
radiographic parameters (time frame: baseline, 3, 6, and 9 months after treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06625528, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2024.